Identifiers
- 510(k) Number
- K200547 FDA 510(k)
- FDA Product Code
- MOF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Traxcess 14 SELECT Guidewire is a medical device classified as a guide wire, catheter, and neurovasculature product. It is designed for use in cardiovascular procedures, specifically in the neurovascular system.
This device is supplied by MicroVention, Inc. and has received FDA 510(k) clearance with a K-number of K200547. It is a Class II medical device and is not specified as single-use or reusable in the provided data.
Frequently asked questions
What is the Traxcess 14 SELECT Guidewire used for?
The Traxcess 14 SELECT Guidewire is designed for use in cardiovascular procedures, specifically within the neurovascular system. It functions as a guide wire, catheter, and neurovasculature product to assist in navigating through blood vessels during medical interventions.
Is the Traxcess 14 SELECT Guidewire single-use or reusable?
The provided data does not specify whether the Traxcess 14 SELECT Guidewire is single-use or reusable. As a Class II medical device with FDA 510(k) clearance, users should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal protocols.
What regulatory approvals does the Traxcess 14 SELECT Guidewire have?
The Traxcess 14 SELECT Guidewire has received FDA 510(k) clearance with K-number K200547, classified as a Class II medical device. It was determined to be substantially equivalent to predicate devices and received special clearance through the Cardiovascular advisory committee.
How is the Traxcess 14 SELECT Guidewire supplied?
The Traxcess 14 SELECT Guidewire is supplied by MicroVention, Inc., a medical device manufacturer based in Aliso Viejo, California. The device is distributed as part of their neurovascular product line for use in cardiovascular procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200547 | Class II | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA 510(k) K200547 24 fields · synced Sep 21, 2026